Study of Platelet Rich Fibrin Combined With Topical Antibiotics or Antiseptics for Treating Chronic Skin Ulcers A Randomized, Double-Blind Pilot Trial Comparing PRF Treatments and Silver Wound Dressing

What this Trial Is About

Researchers are evaluating the effectiveness of platelet rich fibrin PRF combined with topical antibiotics or antiseptics for treating infected chronic wounds. This randomized controlled trial compares three different PRF treatments to an active silver gauze wound dressing, aiming to provide evidence on how PRF works alone and when mixed with antimicrobial compounds. The study focuses on patients with infected chronic venous ulcers and excludes those with certain severe conditions or untreated diabetes. The trial has four treatment groups PRF mixed with amikacin and teicoplanin sprayed onto the wound, PRF with placebo saline spray, PRF combined with polyhexanide and macrogolol spray, and a silver gauze dressing as the control. Participants receive treatment for 56 days, with wound surface area measured at baseline, day 28, and day 56. Infection parameters such as C-reactive protein and leukocyte counts are monitored weekly, and systemic antimicrobial therapy is started if needed based on specialist evaluation. Participants will visit regularly for wound assessments, blood tests, and monitoring of infection signs. Researchers will evaluate wound area reduction after 56 days as the primary outcome, along with secondary outcomes including the need for systemic antibiotics, time to wound sterility, and presence of drug-resistant bacteria. The study includes close monitoring of infection status and safety measures throughout the treatment period.

PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4